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Clinical trials are research studies that test how well new medical approaches work in people. Each one answers scientific questions and looks for better ways to prevent, screen for, diagnose or treat a disease. Some compare a new treatment with one that is already available.
The protocol
Every clinical trial follows a protocol — an action plan that describes:
- what will be done in the study;
- how it will be carried out;
- why each part is necessary.
Who can take part
Each study has its own rules about who can join. For example, a study might need:
- volunteers who have a certain disease;
- healthy people;
- only men, or only women.
Protecting participants: the IRB
Many clinical trials are reviewed, monitored and approved by an Institutional Review Board (IRB) — an independent committee of physicians, statisticians and members of the community. Its job is to:
- make sure the study is ethical;
- protect the rights and welfare of participants;
- make sure the risks are reasonable compared with the potential benefits.
In the United States, a trial must have an IRB if it studies a drug, biological product or medical device regulated by the Food and Drug Administration, or if it is funded or carried out by the federal government.
Sources
Based on the MedlinePlus health topic "Clinical Trials," National Library of Medicine, with text from the National Institutes of Health; works of the United States government in the public domain.
Лицензия: CC0 1.0 (общественное достояние) · По материалам medlineplus.gov
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